Product Safety Recalls

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Boston Scientific Corporation Recall 94240

Description: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

Boston Scientific Corporation Recall 94240 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1655-2024
Event ID94240
Event DescriptionExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
Product TypeDevices
DistributionWorldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Quantity116091 catheters
Recall ReasonAn increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Device Classification20240522
Device Code InfoUDI/DI 08714729187820, Batch Numbers: 60427721, 60437784, 60456288, 60473154, 60481598, 60500737, 60427722, 60443032, 60461431, 60473157, 60481599, 60505121, 60427723, 60443033, 60462014, 60474023, 60481600, 60512236, 60427724, 60443034, 60463401, 60474083, 60481601, 60512384, 60427725, 60443035, 60463402, 60474084, 60488294, 60512385, 60427726, 60443036, 60463600, 60474085, 60488295, 60521834, 60430878, 60443903, 60463954, 60476445, 60488296, 60521835, 60430926, 60443904, 60463955, 60477256, 60488297, 60521836, 60430927, 60443905, 60463967, 60479456, 60488298, 60522587, 60430928, 60443906, 60463974, 60479457, 60492673, 60522901, 60432308, 60443907, 60464492, 60479458, 60492674, 60522902, 60432309, 60446725, 60470527, 60479459, 60492675, 60525059, 60432310, 60448203, 60470528, 60479460, 60492676, 60525077, 60434240, 60448204, 60470530, 60479461, 60492677, 60527362, 60434481, 60448205, 60470531, 60481596, 60498229, 60527363, 60436641, 60452064, 60472576, 60481597, 60498230, 60533639, 60538215
Center Classification Date20240510
Recall Initiation Date20240321
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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